Search Legislation

The Medicines for Human Use (Clinical Trials) Regulations 2004

What Version

 Help about what version
  • Latest available (Revised)
  • Original (As made)

Status:

This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

False or misleading information

50.—(1) Any person who in the course of—

(a)making an application for an ethics committee opinion;

(b)making a request for authorisation to conduct a clinical trial; or

(c)making an application for the grant or variation of a manufacturing authorisation,

provides to the licensing authority or an ethics committee any relevant information which is false or misleading in a material particular shall be guilty of an offence.

(2) Any person who—

(a)is conducting a clinical trial authorised in accordance with these Regulations;

(b)is a sponsor of such a clinical trial;

(c)while acting under arrangements made with a sponsor of such a clinical trial, performs the functions of that sponsor; or

(d)holds a manufacturing authorisation,

and who, for the purposes of these Regulations, provides to the licensing authority or an ethics committee any relevant information which is false or misleading in a material particular shall be guilty of an offence.

(3) Any person who, for the purpose of being engaged as a qualified person in accordance with regulation 43, provides to the licensing authority or to the holder of a manufacturing authorisation any information which is false or misleading in a material particular shall be guilty of an offence.

(4) In this regulation, “relevant information” means any information which is relevant to an evaluation of—

(a)the safety, quality or efficacy of an investigational medicinal product;

(b)the safety or scientific validity of a clinical trial; or

(c)whether, with regard to a clinical trial, the conditions and principles of good clinical practice are being satisfied or adhered to.

Back to top

Options/Help

Print Options

You have chosen to open The Whole Instrument

The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

You have chosen to open The Whole Instrument as a PDF

The Whole Instrument you have selected contains over 200 provisions and might take some time to download.

Would you like to continue?

You have chosen to open the Whole Instrument

The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

You have chosen to open Schedules only

The Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As Enacted or Made):The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as enacted version that was used for the print copy
  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as made version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources